ISSN 1977-7868 EMCDDA–Europol Joint Report on a new psychoactive substance: MDPV (3,4-methylenedioxypyrovalerone) In accordance with Article 5 of Council Decision 2005/387/JHA on the information exchange, risk assessment and control of new psychoactive substances About this series EMCDDA–Europol Joint Report publications examine the detailed information provided by the EU Member States on individual new psychoactive substances. Information is collected from the Reitox network, the Europol national units and the national competent authorities of the European Medicines Agency. Each Joint Report serves as the basis upon which the decision to conduct a risk assessment of the new psychoactive substance is taken. It is part of the three-step procedure involving information exchange, risk assessment and decision-making in the framework of the Council Decision 2005/387/JHA. JOINT REPORTS MDPV EMCDDA–Europol joint publication
34
Embed
JOINT REPORTS - Europolprocedure involving information exchange, risk assessment and decision-making in the framework of the Council Decision 2005/387/JHA. JOINT REPORTS MDPV EMCDDA–Europol
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
ISS
N 1
97
7-7
86
8
EMCDDA–Europol Joint Report on a new psychoactive substance: MDPV (3,4-methylenedioxypyrovalerone)
In accordance with Article 5 of Council Decision 2005/387/JHA on the information exchange, risk assessment and control of new psychoactive substances
About this seriesEMCDDA–Europol Joint Report publications examine the detailed information provided by the EU Member States on individual new psychoactive substances. Information is collected from the Reitox network, the Europol national units and the national competent authorities of the European Medicines Agency.
Each Joint Report serves as the basis upon which the decision to conduct a risk assessment of the new psychoactive substance is taken. It is part of the three-step procedure involving information exchange, risk assessment and decision-making in the framework of the Council Decision 2005/387/JHA.
JOINT REPORTS
MDPV
EMCDDA–Europol joint publication
2 / 34
I Contents
3 I 1. Introduction
3 I 2. Information collection process
4 I 3. Information required by Article 5.2 of the Decision 4 I 3.1 Chemical and physical description, including the names under which the new psychoactive substance is known — Article 5.2(a) of the Decision 5 I 3.2 Information on the frequency, circumstances and/or quantities in which a new psychoactive substance is encountered, and information on the means and methods of manufacture of the new psychoactive substance — Article 5.2(b) of the Decision 5 I 3.2.1 Information provided to Europol 8 I 3.2.2 Information provided to the EMCDDA 9 I 3.3 Information on the involvement of organised crime in the manufacture or trafficking of the new psychoactive substance — Article 5.2(c) of the Decision 10 I 3.4 A first indication of the risks associated with the new psychoactive substance, including the health and social risks, and of the characteristics of users — Article 5.2(d) of the Decision 10 I 3.4.1 First indication of health risks 13 I 3.4.2 Characteristics of users 15 I 3.5 Information on whether or not the new substance is currently under assessment, or has been under assessment, by the UN system — Article 5.2(e) of the Decision 16 I 3.6 The date of notification on the Reporting Form of the new psychoactive substance to the EMCDDA or to Europol — Article 5.2(f) of the Decision 16 I 3.7 Information on whether or not the new psychoactive substance is already subject to control measures at national level in a Member State — Article 5.2(g) of the Decision 17 I 3.8 Further information — Article 5.2(h) of the Decision 17 I 3.8.1 The chemical precursors that are known to have been used for the manufacture of the substance 17 I 3.8.2 The mode and scope of the established or expected use of the new substance 17 I 3.8.3 Other use of the new psychoactive substance and the extent of such use, the risks associated with this use of the new psychoactive substance, including the health and social risks
18 I 4. Information from the EMA as requested by Article 5.3 of the Decision 18 I 4.1 Marketing authorisation 18 I 4.2 Application for a marketing authorisation 18 I 4.3 Suspended marketing authorisation
18 I 5. Conclusions
19 I References
21 I Annexes
I Acknowledgements
The EMCDDA would like to thank the following for their contribution in producing this publication:
I the Early-warning system (EWS) correspondents of the Reitox national focal points (NFPs) and experts from their
national EWS networks;
I the Europol national units (ENUs) and Europol Project Synergy;
I the national competent authorities responsible for human and veterinary medicinal products in the Member States,
Norway and Iceland;
I the European Medicines Agency (EMA) and the European Commission;
I the World Health Organization;
I EMCDDA staff: Brendan Hughes, Isabelle Giraudon, Athanasios Stamos, Marta Rychert and Katarzyna Natoniewska.
Project team: Andrew Cunningham, Michael Evans-Brown, Ana Gallegos, Roumen Sedefov, Anabela Almeida (EMCDDA)
and Daniel Dudek (Europol).
3 / 34
I 1. Introduction
Article 5.1 of Council Decision 2005/387/JHA (1) (hereinafter
referred to as the ‘Decision’) stipulates that ‘Where Europol
and the EMCDDA, or the Council, acting by a majority of its
members, consider that the information provided by the
Member State on a new psychoactive substance merits the
collection of further information, this information shall be
collated and presented by Europol and the EMCDDA in the
form of a Joint Report (hereinafter the “Joint Report”).’ The
Joint Report shall be submitted to the Council, the European
Medicines Agency (EMA) and the Commission.
At the end of September 2013, the European Monitoring
Centre for Drugs and Drug Addiction (EMCDDA) and Europol
examined the available information on a new psychoactive
substance 3,4-methylenedioxypyrovalerone, commonly known
by the abbreviation ‘MDPV’, through a joint assessment based
upon the following criteria:
1. the amount of the material seized;
2. evidence of organised crime involvement;
3. evidence of international trafficking;
4. analogy with better-studied compounds;
5. evidence of the potential for further (rapid) spread; and,
6. evidence of cases of serious intoxication or fatalities.
The EMCDDA and Europol agreed that the information
collected on MDPV satisfied criteria 1, 2, 3, 4 and 6. The two
organisations therefore concluded that sufficient information
had been accumulated to merit the production of a Joint
Report on MDPV as stipulated by Article 5.1 of the Decision.
I 2. Information collection process
In compliance with the provisions of the Decision, on 7
October 2013 the EMCDDA and Europol launched a
procedure for the collection of information on MDPV, in order
to prepare the Joint Report. The information was collected
mainly through the Reitox National Focal Points in the Member
States, Turkey and Norway as well as the Europol National
Units. In addition, the EMA collected information through the
national competent authorities responsible for human and
veterinary medicinal products in the Member States as well as
in Norway and Iceland. The information collection process was
largely concluded by 18 November 2013; additional
information and clarifications from some countries were
received up to four weeks after this date.
(1) OJ L 127, 20.5.2005, p. 32.
Europol asked the Europol National Units to provide
information on:
n the level of production of MDPV in their country;n the level of distribution of MDPV in their country;n the level of trafficking of MDPV in their country, both for
internal, transit or export purposes;n the number of seizures of MDPV in their country, the total
amount of the seizures, country of origin, details on the
physical forms (including photos);n the role of organised crime, or criminal groups, in the
production, distribution and trafficking of MDPV in their
country; and,n any known aspect of violence and/or money laundering
relating to the production and trafficking of MDPV.
Europol received responses from 15 Member States.
According to Article 5.3 of the Decision, the EMA asked the
national competent authorities responsible for human and
veterinary medicinal products in the Member States as well as
in Norway and Iceland to provide information on whether:
n the new psychoactive substance MDPV has obtained a
marketing authorisation;n the new psychoactive substance MDPV is the subject of an
application for a marketing authorisation; and,n a marketing authorisation that had been granted in respect
of the new psychoactive substance MDPV has been
suspended.
Twenty-five Member States (2), Norway and Iceland replied to
the EMA’s request. The EMA also provided information as
relevant to the central authorisation procedure.
Furthermore, in anticipation of Article 7.3 of the Decision in
relation to the manufacturing of medicinal products in the
European Union, the EMA also requested whether the new
psychoactive substance MDPV is used to manufacture a
medicinal product:
n which has been granted a marketing authorisation;n for which an application has been made for a marketing
authorisation; and,n for which a marketing authorisation has been suspended
by a competent authority.
(2) Austria, Belgium, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom.
JOINT REPORTS I MDPV
4 / 34
Twenty-four Member States (3), Norway and Iceland replied to
the EMA’s request. The EMA also provided information as
relevant to the central authorisation procedure.
The EMCDDA collected data through:
1. a structured questionnaire from the Reitox national focal
points. The EMCDDA received replies from 28 Member
States as well as Norway and Turkey;
2. data previously provided to the EU early-warning system
(EWS) in EMCDDA–Europol Reporting Forms, EWS
Progress and Final Reports;
3. a specific information request to the World Health
Organization on whether or not MDPV is under assessment
by the United Nations system (see section 3.5); and,
4. a structured search of the scientific literature and of
relevant Internet sites.
Thus, information included in sections 3.2.1 and 3.3 of the
Joint Report was provided by Europol, while the EMCDDA
provided information included in sections 3.1, 3.2.2, 3.4, 3.5,
3.6, 3.7, 3.8.1, 3.8.2 and 3.8.3 (in part). The information
included in sections 3.8.3 (in part), 4.1, 4.2 and 4.3 was
provided by the EMA. The conclusion of the Joint Report were
prepared and agreed by the two organisations responsible —
the EMCDDA and Europol. Further details of the seizures and
collected samples (including images where available) reported
to the EMCDDA are provided in Annex 1. The details of deaths
associated with MDPV that have been reported to the
EMCDDA are provided in Annex 2.
I 3. Information required by Article 5.2 of the Decision
The order and titles of subsections 3.1 to 3.8 and section 4
below are as they appear in Article 5.2(a) to (h) and Article
5.3(a) to (c) of the Decision; all sections are cross-referenced
with those set down in the Decision.
(3) Austria, Belgium, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom.
I 3.1. Chemical and physical description, including the names under which the new psychoactive substance is known — Article 5.2(a) of the Decision
Chemical description and names
MDPV is a synthetic derivative of the naturally occurring
substance cathinone, one of the psychoactive principles in
khat (Catha edulis Forsk). All monitored synthetic cathinone
derivatives are either N-alkylated or the nitrogen atom is part
of a pyrrolidine ring, which is the case with MDPV. Most of the
cathinone derivatives are also ring-substituted and MDPV
contains the 3,4-methylenedioxy substitution pattern on the
phenyl ring that is observed in other illicit drugs such as
MDMA (3,4-methylenedioxymethamphetamine).
Pyrrolidine derivatives, such as MDPV, can be regarded as a
subset of cathinone derivatives sharing the same structural
skeleton as pyrovalerone (Figure 1). Other examples in this
group are 1-phenyl-2-(1-pyrrolidinyl)-1-pentanone (α-PVP) and
4-methyl-α-pyrrolidinobutyrophenone (MPBP).
MDPV is the common name for
3,4-methylanedioxypyrovalerone. The systematic chemical
name is: (RS)-1-(benzo[d][1,3]dioxol-5-yl)-2-(pyrrolidin-1-yl)
‘OLGA’, ‘LENA’, ‘EVA’, ‘CLARA’, ‘MARKETA’ and ‘JANA’.
Chemical Abstract Service registry numbers (CAS RN)
687603-66-3 free base
24622-62-6 hydrochloride salt
1388142-27-5 R-enantiomer base
1388142-28-6 S-enantiomer base
1246912-12-8 deuterated (D8) base
1246820-09-6 deuterated (D8) hydrochloride salt
The REACH registered substances database hosted by the
European Chemicals Agency (ECHA) was searched using the
CAS registry numbers listed above. The search returned no
results.
Physical description
The free base form of MDPV has been described as a brown or
yellow-green amorphous powder. The hydrochloride salt form
is described as a white-tan crystalline hygroscopic powder
with a melting point of 238–239oC.
Reports from seizures and collected samples have noted the
presence of MDPV in: powders, powder-filled capsules,
tablets, blotters (small paper doses for sublingual/buccal
administration), liquids and vegetable material, and in residues
on injecting equipment.
A more detailed description of MDPV seizures and collected
samples encountered can be found in subsections 3.2.1 and
3.2.2 below.
I 3.2. Information on the frequency, circumstances
and/or quantities in which a new psychoactive substance is encountered, and information on the means and methods of manufacture of the new psychoactive substance — Article 5.2(b) of the Decision
3.2.1. Information provided to Europol
Europol received replies from 15 Member States (Belgium,
Italy, Latvia, Lithuania, Luxembourg, Poland, Slovakia and
Slovenia). Of these, four countries had no data relating to
MDPV (Cyprus, Latvia, Luxembourg and Slovenia). The
remaining 11 countries (Belgium, Bulgaria, Croatia, Estonia,
Finland, Germany, Hungary, Italy, Lithuania, Poland and
Slovakia) reported the following information.
The level of production, distribution and trafficking
Belgium reported that in 2013 there were eight cases in total,
where MDPV was sent from China and entered Belgium en
FIGURE 1
The molecular structure, weight and monoisotopic mass of MDPV. The molecular structure for pyrovalerone is provided for comparison (* denotes the chiral centre).
O
O
O
N*
O
N*
MDPV Pyrovalerone
Molecular formula: C16
H21
NO3
Molecular weight: 275.3429
Monoisotopic mass: 275.152
JOINT REPORTS I MDPV
6 / 34
route to third countries. The final destinations in these cases
were: Italy (three cases), the Netherlands (three) and the
United Kingdom (two). The seized MDPV destined for Italy
ranged from 18 g to 510 g. On two occasions the substance
was labelled as ‘ULTRAVIOLET AB’ (18 g and 510 g) and as
‘LITHOPHONE’ (100 g) on the other occasion. The MDPV
ordered by consumers in the Netherlands was labelled as
‘SODIUM ALGINATE’, with the following quantities seized:
1 516 g, 1 521 g and 2 022 g. In one of the two cases when
MDPV was destined for the United Kingdom market (which
weighed 260 g in each case), the seized substance was
labelled as ‘HETASTARCH’.
Bulgaria reported that customs authorities had reported 12
seizures of MDPV between July 2010 and March 2012. All
seizures took place at Sofia Airport, and the substance had
been sent to Bulgaria (in the majority of cases) from China,
Spain, Portugal, the United Kingdom or the Netherlands. One
case was reported that involved almost 5 000 small packages
of MDPV being sent to Poland via Hungary. In these 12
seizures, 5 267 g and 300 tablets of MDPV were seized. In
some cases MDPV powder was mixed with caffeine and
lidocaine. MDPV tablets were pink in colour, with an elliptic
shape and were packed in small packages (containing two
tablets each) bearing the label: ‘DOVES RED’. MDPV in
powder form was identified in small packages bearing
different labels, for example, ‘IVORY WAVE’, ‘MOJO’, ‘FLOWER
MAGIC POWDER’ and ‘LOAD’.
The Bulgarian authorities also reported that the Research
Institute of Forensic Sciences and Criminology of the Ministry
of the Interior has recorded 19 cases related to MDPV
seizures. In some of these cases MDPV was destined for
‘smart shops’ located in nearby resorts on the Black Sea.
Croatia reported that MDPV was detected in 10 cases (14 g in
total).
Estonia reported one seizure of MDPV (1.68 g), made by
customs authorities in incoming mail from the United
Kingdom. In this case, MDPV was mixed with alpha-PVP and
pentedrone.
Finland reported that the number of seizures of MDPV had
been higher a few years ago. Since the substance was
classified as a controlled substance, the number had declined.
According to data provided by Finland, there were eight
incidents where MDPV was seized in powder form (63.5 g in
total). There is also information that MDPV was identified in 11
blood samples (no further details were provided to Europol).
The German report to Europol mentioned two significant
investigations during which seizures of MDPV were recorded.
The first investigation was conducted between September
2011 and March 2013. It focused on the distribution of new
psychoactive substances sold via the Internet as so-called
‘legal high’ products. During house searches made in March
2013, a total of 5 524 products containing new psychoactive
substances (NPS) were seized. Moreover, during further mail
confiscation another 3 999 NPS products were seized. Among
these, the following products contained MDPV:
10 packages (1 g each) of the ‘bath salt’ labelled
‘Charlie Sheen’;
11 packages (1 g each) of the ‘bath salt’ labelled ‘Mojo’;
20 capsules (0.5 g each).
Further analysis revealed that more than 4 000 customers
from Germany and other countries had used this now-
disrupted network. The NPS products were ordered by
wholesalers in Belgium, the Netherlands, the Czech Republic,
Portugal and Belize.
The second German investigation involved online vendors who
were involved in supplying MDPV and methoxetamine. In the
framework of this investigation, 30 kg of different NPS
products were seized. Amongst others, the following seizures
of MDPV were identified:
4 packages (1 g each) of the ‘bath salt’ labelled
‘highway’;
6.29 g of a white powder labelled ‘4-FMP’;
13.58 g of a white powder labelled ‘MDPV’;
0.94 g of a white powder labelled ‘ECKO’, mixed with
caffeine;
a total of 90 g of a white powder with various labelling:
‘MDPV’, ‘methylone’, ‘4-FA’, with a purity of 73 %;
The seizures of MDPV ranged from 0.02 g (March 2012) to
1 kg (January 2013, made up of 2 x 500 g).
In Hungary the increase in availability, use and distribution of
MDPV led the Ministry of Justice to propose an amendment to
the Act on Drugs that then placed MDPV as a Class A drug.
The Hungarian Europol Liaison Officer reported that MDPV
was seized in tablet and powder form in 2009 and 2010
respectively. Seizures of MDPV tablets increased from 551
tablets in 2009 (six cases) to 8 522 tablets in 2012 (nine
cases). Seizures of powder have increased from 133 g in 2010
(4) Tony Montana is the name of Al Pacino’s character in the 1983 film Scarface, directed by Brian de Palma, which tells the story of a Cuban refugee who becomes a drug kingpin in the cocaine trade in Miami, USA.
to 9 579 g in 2010 and to 5 730 g in 2012. It has been noted
that in 2013 the seizures of MDPV (both tablets and in powder
form) fell significantly.
Italy reported a limited number of seizures of MDPV. Three
seizures of MDPV (in total 307.6 g) were made in the
provinces of Roma, Milano and Taranto (September–October
2013). Italian citizens were reported to be involved in these
cases.
Lithuania reported four seizures of MDPV made in 2012,
totalling 1.326 g.
In Poland, MDPV was seized as powder in quantities ranging
from 0.11 g to 525 g. The largest seizure, in April 2013, when
the substance was sent from China (ordered via www.
sensearomatic.com) to Poland by shipping company FedEx.
Slovakia reported 24 cases where MDPV was seized as a
powder (various colours). In a significant majority of cases, the
substance was seized in small packages labelled with various
Way’ (one); ‘Popeyes Sniff’ (one) and ‘LP’ (one). In almost all
cases, MDPV was identified in a mixture with other new
psychoactive substances, such as: 2-DPMP (5) and
buphedrone (the majority), MABP, bk-MDMA and
ethcathinone. Seizures of MDPV weighed between 0.218 g
and 53.315 g.
The Slovakian Financial Administration reported a case
focused on a ‘smart shop’ (Euphoria Shop Ltd) that distributed
goods called ‘Aromatic herbs and imitations of spa salts’. The
Forensic Institute revealed that the products contained MDPV.
The goods were distributed via branches in six cities in
Slovakia. In June 2012, during searches made in these
branches and in the house of a suspect, a total amount of
19 562 packages containing MDPV were seized. In addition,
five plastic bags with crystalline white powder (20 g, 80 g,
300 g, 800 g, 1 kg) and EUR 6 191 in cash were seized.
Slovakia also reported a seizure of 10 kg of MDPV powder by
customs officers of the Airport Financial Administration (no
other details provided).
According to Slovakian authorities, imports are ordered via the
Internet and then delivered from China to Slovakia by mail
order (DHL, TNT, FedEx, etc.).
No reports were received that indicated licit or illicit
production of MDPV in any of these countries.
(5) 2-(Diphenylmethyl)piperidine.
JOINT REPORTS I MDPV
8 / 34
3.2.2. Information provided to the EMCDDA
According to reports to the EMCDDA, MDPV has been present
on the EU drugs market since 2008 and subsequently a large
volume of data has been collected during this period, of which
a summary is presented below.
Twenty-seven Member States (all Member States with the
exception of Luxembourg), Norway and Turkey reported
detections of MDPV (6).
Seizures
Twenty-seven Member States (all Member States with the
exception of Luxembourg), Norway and Turkey reported
seizures (7) of MDPV to the EMCDDA. In excess of 5 500
seizures have been reported, with two countries reporting
more than 1 000 seizures each: the United Kingdom (1 704)
and Finland (1 340). A further four countries reported more
than 100 seizures: Hungary (599), Poland (401), Ireland (242)
and Spain (176).
MDPV has typically been seized in powder form (reported by
all countries where MDPV was detected). Some countries also
reported seizures of tablets or powder-filled capsules (Finland,
France, Germany, Hungary, Italy, Lithuania, the Netherlands,
Norway, Poland, Portugal, Romania, Spain, Sweden and the
United Kingdom). Six countries (Denmark, Finland, France,
Latvia, Sweden and the United Kingdom) have seized liquids
containing MDPV. Finland and Poland each reported a single
seizure of paper doses (also known as a ‘blotters’), i.e. small
pieces of paper impregnated with MDPV for sublingual/buccal
administration. The Polish blotters (four in total) had an image
of Bugs Bunny on them and also contained 2-DPMP,
ethylphenidate and the nootropic substance piracetam.
Hungary also reported two cases where MDPV was present as
‘powder on herb’ and Poland reported a seizure of a ‘legal
high’ product labelled as ‘Greenway Speedway’, which
contained vegetable material with MDPV present. Indeed,
MDPV has often been found as an ingredient in so-called
‘legal high’ products, often in combination with other
substances. Several countries have described these as ‘bath
salts’, a term frequently used to describe ‘legal high’ products.
(6) ‘Detections’ is an all-encompassing term and may include seizures and/or collected and/or biological samples. Seizure means a substance available (seized) through law enforcement activities (police, customs, border guards, etc.). Collected samples are those that are actively collected by drug monitoring systems (such as test purchases) for monitoring and research purposes. Biological samples are those collected from human body fluids (urine, blood, etc.) and/or specimens (tissues, hair, etc.).
(7) Many ‘seizures’ relate to individual case-level data. However, some data provided to the EMCDDA are aggregated at the country level. Some of the data from the United Kingdom are reported as ‘records’, where several records may come from the same case. Data is drawn from the Joint Report questionnaires and data provided in the bi-annual data gathering (EWS Progress and Final Reports) and from individual Reporting Forms submitted on an ad hoc basis.
Several of these products carry names that are associated
with or similar to street names used for cocaine, amphetamine
or ‘ecstasy’ (MDMA). Other substances found along with
MDPV in the same preparation include a wide range of new
psychoactive substances (predominantly cathinones, but also
agonists and a range of other substances), adulterants such
as benzocaine, lidocaine and caffeine, and in a smaller
number of cases with substances that are internationally
controlled or controlled at the EU level.
Where information has been provided, quantities of powder
for single seizures ranged from 0.02 g (Germany and Poland)
to 5 kg (Czech Republic). Hungary reported a seizure of 300
yellow tablets bearing a heart logo and a separate seizure of
two white tablets bearing markings resembling the Louis
Vuitton ‘LV’ logo (8). Norway reported a seizure of 98 purple
tablets bearing a space ship/rocket logo. These tablet findings
may suggest that MDPV is being sold as ’ecstasy’. There were
also unmarked tablets reported in a variety of colours,
including white, grey, pink, reddish and green, although many
of these were associated with ‘legal high’ products. A
selection of images is provided in Annex 1.
More than 4 500 individual cases of MDPV powder have been
reported, amounting to an excess of 200 kg of seized MDPV.
The vast majority of these are small cases; however, 45 of
them (reported by the Czech Republic, Finland, France,
Hungary, Latvia, the Netherlands, Spain and Sweden) were in
excess of 500 g, accounting for more than approximately
one-third of the total weight of powder seized. In 2011, for
example, customs authorities in Hungary made seven
separate seizures of MDPV powder amounting to
approximately 14.5 kg. Belgium, the Czech Republic, Germany
and Lithuania provided information that MDPV seized by
customs authorities had been sent from China. No other
non-EU countries were identified in the reports, although two
Member States reported the interception of packages sent
from another Member State. Several countries reported MDPV
in powders contained in ‘legal high’ products with names such
as ‘Charlie Sheen’, ‘Synthacaine’ or ‘Speedway Pro’ (a full list
of names is provided in Section 3.1 above).
There were over 500 cases involving MDPV tablets or
capsules, containing approximately 30 000 tablets in total.
Several countries reported tablets containing MDPV in
branded ‘legal high’ products with names such as ‘Yellow
Submarine’, ‘Doves Red’ and ‘Mind Candy’ (a full list of names
is provided in Section 3.1 above).
(8) It is common to find markings on tablets sold as ‘ecstasy’ that copy those of popular cultural and iconic brands that are associated with quality. Louis Vuitton is a French fashion label.
JOINT REPORTS I MDPV
9 / 34
Biological samples
Eleven countries reported detections of MDPV in biological
samples, including:
n a total of 99 deaths: Finland (40 deaths), United Kingdom
(32), Sweden (21), Poland (three), Austria (one), France
(one) and Norway (one) – see section 3.4.1 and Annex 2 for
further details;n 107 analytically confirmed non-fatal intoxications: Sweden
(99 cases), France (three), Italy (three) and Belgium (two);n detections related to cases of suspicion of driving under
the influence of drugs (Finland: 514 in the period 2009–13;
Poland: one); driving under the influence of drugs and other
crimes (Norway: nine; United Kingdom: one); drug testing
(Poland: one); and unspecified detections in biological
samples (Sweden: 842; Hungary: 387; United Kingdom: six;
Norway: six).
Collected samples
In addition to the detections of MDPV in seizures and
biological samples, ten Member States (Austria, Cyprus,
Denmark, France, Ireland, Italy, the Netherlands, Poland,
Slovakia and the United Kingdom) also reported collected
samples.
In Austria 32 samples of powder were collected and analysed
as part of the ‘pill’-testing project run by ‘ChEckiT!’ between
2010 and 2013. The samples were sold as mephedrone,
cocaine, MDPV and speed. In two cases, amphetamine and
caffeine or bk-MBDB (9) were also detected.
France reported nine samples of powder collected from
different venues. Where quantitative information is available,
the weight ranged from 0.1 g to 0.5 g. In two of the samples,
alpha-PVP and pentedrone were also detected; in the other
sample alpha-PVP and caffeine were detected. In one of the
cases the sample was sold as cocaine.
In Ireland MDPV was identified in products collected from
head shops, branded ‘Hurricane Charlie’, ‘Dogs Bollix’, ‘Doves
Red’, ‘Doves Ultra’, ‘Ivory Wave’, ‘Sextasy’, ‘Orange Orbits’ and
‘Stardust’.
In the Netherlands, the Drugs Information and Monitoring
System (DIMS) detected MDPV in 27 samples (11 in 2010;
nine in 2012; seven in 2013). Where information is provided,
the samples were sold at consumer level as MDPV (one
(9) 2-Methylamino-1-(3,4-methylenedioxyphenyl)butan-1-one, also known as butylone.
JWH-122, JWH-081), TFMPP, 5-HTP, creatine, lidocaine and
caffeine.
Slovakia reported a total of 304 collected samples; some of
them were offered through online shops (i.e. www.
euphoriashop.sk, www.hypnotic.sk) under a variety of names
including ‘Beep Beep’, ‘Long Play’, ‘Popeyes Sniff’, ‘Speed
Way’, etc. Other substances often detected in the samples
include the synthetic cathinones buphedrone,
N-ethylcathinone and methylone, 2-DPMP and piracetam.
A small number of collected samples were reported by
Cyprus, Denmark, Italy and the United Kingdom. In 2010
Cyprus reported MDPV in two samples of a product of 500 mg
labelled ‘Ivory Wave’. Denmark reported three samples of
powder in 2013. Italy reported a sample of 0.5 g of white
powder purchased from the Internet and labelled ‘Ivory Wave’.
On the label on the back of the package, ingredients listed
were ‘water softening agents, Epsom salts, sodium
bicarbonate, sodium chloride, amino acid blends, and naturally
occurring trace elements and minerals’. No other substances
in addition to MDPV were detected. The United Kingdom
reported a sample of 33 g of MDPV powder purchased from
an Internet retailer (www.chembay.co.uk) in December 2008.
Further details of these collected samples, including
information on the product labels, are provided in Annex 1.
I 3.3. Information on the involvement of organised crime in the manufacture or trafficking of the new psychoactive substance — Article 5.2(c) of the Decision
According to German authorities there are no links to suggest
the involvement of organised crime groups in the production,
trafficking and/or distribution of MDPV. It should be borne in
mind that easy access to substances (which can be in large
amounts) within and outside the European Union via Internet
shops indicates at least a certain level of organisation. In
addition, organised crime groups’ interest and presence in the
phenomenon of new psychoactive substances can be easily
concluded from the substantial profits that can be obtained
from this type of activity.
Money laundering aspects
No information was received on money laundering in
connection with the production and/or trafficking of MDPV.
Violence in connection with production, wholesale and
distribution
No information was received on incidents of violence in
connection with the production, wholesale and/or trafficking
of MDPV.
I 3.4. A first indication of the risks associated with the new psychoactive substance, including the health and social risks, and of the characteristics of users — Article 5.2(d) of the Decision
3.4.1. First indication of health risks
Up to 107 non-fatal intoxications and 99 deaths, analytically
confirmed to be associated with MDPV, were reported by
Austria, Belgium, Finland, France, Italy, Poland, Sweden, the
United Kingdom and Norway. Germany, Greece, Hungary,
Ireland and Slovakia have also reported cases, which have not
been described below due to their non-confirmed status.
Non-fatal intoxications
Belgium
Belgium reported two analytically confirmed, linked non-fatal
intoxications in which the patients presented were stimulated,
hypertensive and tachycardic. Traces of cocaine and
amphetamines were also detected in urine samples (not
quantified). They both reported visual and auditory
hallucinations, severe psychosis and paranoia, and were
aggressive. They were treated with antipsychotics and their
status returned to normal after three to four days.
France
France reported three analytically confirmed non-fatal
intoxication cases. In one case, the police brought a man in to
the emergency department. In this case, delirium syndrome
was reported, including hallucinations, as well as
myocardial infarction, rhabdomyolysis and renal failure. A few
patients needed therapy with sedatives for several days due
to prolonged symptoms. It was noted by the authors that
among the people that have come to medical attention, the
incidence of severe poisonings (PSS 3) was highest for MDPV.
Deaths
There were 99 deaths associated with MDPV that were
analytically confirmed. These were reported by Austria (one),
Finland (40), France (one), Poland (three), Sweden (21), the
United Kingdom (32) and Norway (one) (17).
Austria
Austria reported one death, which occurred in January 2012.
The case involved a ‘young man’ who died from butylone
(bk-MBDB) overdose in combination with MDPV, methylone
and 4-MEC. No further details were provided.
(16) There is a potential that there may be an overlap of some cases reported by Lindeman et al., 2013 and the cases reported by Bäckberg et al., 2013
(17) Hungary reported two indirect deaths, which occurred in November 2011. No further details were provided and it is not known if these cases are analytically confirmed.
Finland
Finland reported 40 deaths, which occurred between
September 2009 and August 2013. The cases were all
analytically confirmed, and where the concentration of MDPV
was reported (20 cases) it ranged from 20 mg/mL to
4 800 mg/mL in blood; in all but one case, up to seven other
substances were detected. In 14 cases, five or more
substances were detected in addition to MDPV. The most
frequently encountered other substances detected were
Simmler et al. (2013), using a human in vitro model, assessed
the blood–brain permeability of MDPV. They reported that
MDPV exhibited particularly high blood–brain barrier
permeability as compared to other synthetic cathinones (with
the exception of mephedrone) as well as reference
compounds such as MDMA and amphetamine. In addition,
they reported that the data for MDPV was consistent with
active transport across the blood–brain barrier. The authors
concluded that the potency of MDPV at the DAT and NET and
high blood–brain barrier permeability could ‘result in high
sympathomimetic toxicity and risk of addiction in humans’.
No studies were identified that have examined the
pharmacology and mode of action of MDPV in humans.
Meyer et al. (2010) and Strano-Rossi et al. (2010) provide data
on the possible metabolites and metabolic pathways for
MDPV in vitro using rat and/or human urine and human liver
microsomes.
(20) See also Gregg and Rawls (2013), Huang et al. (2012).
JOINT REPORTS I MDPV
13 / 34
TABLE 1
Transporter-mediated inhibition of uptake and stimulation of release in rat brain synaptosomes. Values are given as nM ± S.E.M. for N=3–4 experiments per drug. E
max % refers to percentage of maximal release response. Key: ‘—’ indicate that compounds
failed to elicit >30 % of the maximal response and therefore compounds are considered inactive in the release assay. Modified from Baumann et al. (2013a, 2013b)
In most of the cases of non-fatal intoxications and deaths
reported by the Member States, other new psychoactive
substances and/or controlled drugs were detected in
biological samples (Section 3.4.1 and Annex 2).
Subjective effects
No studies were identified that have examined the subjective
effects of MDPV in humans; information is largely limited to
that provided in case reports/series (see ‘non-fatal
intoxications’ and section above) and self-reported
experiences from user websites. Table 2 provides an overview
of the self-reported duration of effects when MDPV is taken by
the oral and insufflated routes as reported by Erowid (2013c).
JOINT REPORTS I MDPV
15 / 34
Table 3 provides an overview of subjective effects of MDPV as
reported by Erowid (2013c). In both cases the information was
collated from users, research and other resources. No further
details were provided on the methodology used to collate this
information. Information provided in case reports and case
series of non-fatal intoxications associated with MDPV appear
to support some of these effects. The section on ‘non-fatal
intoxications’, above, provides an overview of the other
adverse effects reported to be associated with MDPV.
TABLE 2
Examples of self-reported duration of effects of MDPV per route of administration (tentative) as reported by Erowid (2013c). No information on the doses that were used was provided
Duration of effects for MDPV Oral Insufflated
Total duration 2.0–7.0 hrs 2.0–3.5 hrs
Onset 15–30 mins 5–20 mins
Coming Up 30–60 mins 15–30 mins
Plateau 30–180 mins 30–100 mins
Coming down 30–120 mins 30–60 mins
After effects 2–48 hours 1–7 days
Hangover/day after ? ?
TABLE 3
Examples of subjective effects of MDPV as reported by Erowid (2013a). No information on the doses that were used was provided
Subjective effects of MDPV
Positive Stimulation (mental and physical)Euphoria, mood liftIncreased sociability/talkativenessIncreased productivity and motivationIncreased mental clarityEnhanced creativityFeelings of empathySexual arousal
Neutral Stimulation (mental and physical)Mild elevation in heart rate
Negative (Likelihood of negative side effects increases with higher doses)Tightened jaw muscles, grinding teeth (trismus and bruxia)Reduced enjoyment of eating/loss of appetiteDisturbed sleep patternsInvoluntary body movements (twitching, lip-smacking, etc.)Confusion and/or scrambled thoughtsGastrointestinal disturbanceMuscle tensionResidual depressed moodNystagmus/eye spasmAnxiousness/nervousness/paranoiaHarsh comedown effectsFiending (re-dosing repeatedly without planning to do so)Excessive excitation/hyperactivityHeadacheVery elevated heart rateHallucinations/psychotic behaviour (at high doses or with repeated use)
Availability, supply, price
A search of google.com using the search string ‘buy “MDPV”’
conducted by the EMCDDA in December 2013 for the Joint
Report identified a number of online shops offering MDPV for
sale in both retail and wholesale quantities. In the former case,
MDPV may be sold as a ‘research chemical’.
Data from the National Drug and Alcohol Research Centre’s
deep web monitoring programme of the Silk Road
marketplace (22,23) (Van Buskirk et al., 2013) identified seven
retailers in early February 2013 offering MDPV for sale. Details
of the specific quantities and prices were not provided. The
number of such retailers was relatively stable over the
preceding four months of monitoring (24). It is important to
note that the study was conducted before Silk Road was
seized and taken offline in October 2013 by the United States
Federal Bureau of Investigation. No studies were identified
that have examined the sale of MDPV since Silk Road has
reopened.
Seizure data and information from collected samples reported
by the Member States suggest that MDPV is sold as a drug in
its own right and directly on the illicit drug market as cocaine,
amphetamine, MDMA and mephedrone.
I 3.5. Information on whether or not the new substance is currently under assessment, or has been under assessment, by the UN system — Article 5.2(e) of the Decision
The World Health Organization is the specialised United
Nations agency designated for the evaluation of the medical,
scientific and public health aspects of psychoactive
substances under the Single Convention on Narcotic Drugs,
1961 and the Convention on Psychotropic Substances, 1971.
On 10 October 2013, the World Health Organization informed
the EMCDDA that MDPV is currently under assessment and
‘the critical review report will be published only early next year
(probably April)’.
(22) The National Drug and Alcohol Research Centre (NDARC) is based at the University of New South Wales, Sydney, Australia.
(23) Silk Road is an anonymous, international online marketplace that operates as a Tor hidden service. It uses the peer-to-peer payment network and digital currency Bitcoin for monetary transactions. The original Silk Road marketplace was seized and taken offline on 2 October 2013 by the United States Federal Bureau of Investigation. Since then a new version of Silk Road, sometimes described as ‘Silk Road 2.0’, has become operational. See Christin (2012) for an overview of the original Silk Road.
(24) Nine retailers were identified in late October 2012; 10 in mid-November 2012; 10 in late November 2012; 10 in mid-December 2012; nine in early January 2013; and nine in mid-January 2013. See Christin (2012) for a discussion of some of the market characteristics and dynamics of the original Silk Road.
JOINT REPORTS I MDPV
16 / 34
Article 7.1 of Council Decision states that ‘no risk assessment
shall be carried out in the absence of a Europol/EMCDDA
Joint Report. Nor shall a risk assessment be carried out where
the new psychoactive substance concerned is at an advanced
stage of assessment within the United Nations system,
namely once the WHO expert committee on drug dependence
has published its critical review together with a written
recommendation, except where there is significant new
information that is relevant in the framework of this Decision’.
The Joint Report has been produced on the understanding
that MDPV is not at an advanced stage of assessment within
the United Nations system.
I 3.6. The date of notification on the Reporting Form of the new psychoactive substance to the EMCDDA or to Europol — Article 5.2(f) of the Decision
The first official EMCDDA–Europol notification of MDPV dates
from December 2008 from the Finnish National Focal Point.
The Reporting Form details a seizure of two quantities of white
powder (each of 1 g) intercepted by customs authorities on 24
November 2008 in incoming mail. The powders were in
packages marked ‘1-(3,4-methylenedioxyphenyl)-2-
pyrrolidinyl-pentan-1-one, purity 99 +%, 1g’. Identification was
based on the analytical technique of GC-MS (25).
MDPV was added to the list of new psychoactive substances
monitored by the EMCDDA and Europol through the European
Union early-warning system and a profile of the substance
was created in the EMCDDA European Database on New
Drugs (EDND). Since then, analytical details, background
information and information relevant to public health have
been exchanged between EMCDDA, Europol and the Member
States on an ad hoc basis. The Commission and the EMA were
kept duly informed.
I 3.7. Information on whether or not the new psychoactive substance is already subject to control measures at national level in a Member State — Article 5.2(g) of the Decision
Twenty Member States (Belgium, Bulgaria, Croatia, Cyprus,
the Czech Republic, Denmark, Estonia, France, Germany,
Slovakia, Slovenia, Sweden, and the United Kingdom), as well
as Turkey and Norway control MDPV under drug control
legislation.
(25) Gas chromatography-mass spectrometry.
In Belgium it was added to the list of substances on 20 March
2013. In Bulgaria it has been controlled under the Narcotic
Substances Control Law since February 2011. In Croatia it is
included in the list of drugs, psychotropic substances, plants
used to produce drugs and substances that can be used in the
production of drugs. In Cyprus it is controlled under the
Narcotic Drugs and Psychotropic Substances Law of 1977 as
a class B drug that is covered by the generic definition of
cathinones. In the Czech Republic it has been included in the
Act 167/1998 Coll. on Addictive Substances. In Denmark it is
covered by the Executive Order on Euphoriant Substances. In
Estonia it has been listed in the Regulation No.73 of the
Minister of Social Affairs since 29 November 2010. In Finland
it has been listed in the Narcotics Act 373 of 2008 since 28
June 2010. In France it was added to the controlled narcotic
substance list since 2 August 2012. In Germany it has been
included in the list covered by the Narcotic Substance Law
since 26 July 2012. In Hungary it is listed in Schedule A
(psychotropic substances) of Act XXV of 1998 on human
pharmaceuticals. In Ireland it has been covered by the Misuse
of Drugs Acts since 11 May 2010. In Italy it has been
controlled generically, as it is a derivative of 2-amino-1-phenyl-
1-propanone, under the Decree of the President of the
Republic 309/90 since 29 December 2011. In Latvia it is
controlled according to Cabinet Regulation 847 ‘Regulations
regarding narcotic substances, psychotropic substances and
precursors to be controlled in Latvia’. In Luxembourg it has
been controlled by the drug control legislation since 30 July
2012. In Poland it is covered by the Act of 15 April 2011
amending the Act of Counteracting Drug Addiction. In Slovakia
it is in the first schedule of psychotropic substances set by the
Act. No 139/1998 Coll. as amended by the Act. No 43/2011
Coll., which came into force on 1 March 2011. In Slovenia it
was included by the Decree on amending the Decree on
Classification of Illicit Drugs, Official Gazette of RS No.
62/2013. In Sweden it comes under the Narcotic Drugs
Control Act (SFS 1992-860) and the Narcotic Drugs Control
Ordinance (SFS 1994-1554). In the United Kingdom it was
included in the generic definition of substituted cathinone
derivatives placed under the Misuse of Drugs Act 1971 in April
2010. In Turkey it is listed in the Law on Control of Narcotics
no.2313. In Norway it has been included by generic scheduling
since 14 February 2013.
Three Member States (Austria, Portugal and Romania) control
MDPV under legislation penalising unauthorised supply of
defined or qualifying new psychoactive substances. In Austria
it is controlled under the generic definition within the New
Psychoactive Substances Act. In Portugal it is listed as
controlled under Decree-Law 54/2013. In Romania, Law
194/2011 subjects to control any psychoactive substance
that qualifies by conforming to certain criteria (all substances
with psychoactive potential are subject to control until proven
harmless by a special designated commission).
JOINT REPORTS I MDPV
17 / 34
In the Netherlands, MDPV sold in consumer amounts is
treated as being a medicinal product and must comply with
medicines legislation (and general product safety legislation).
Greece, Lithuania and Malta have reported that MDPV is not
subject to control measures at the national level.
No information was provided regarding the control status of
MDPV in Spain.
I 3.8. Further information — Article 5.2(h) of the Decision
3.8.1. The chemical precursors that are known to have been used for the manufacture of the substance
No information was reported by the Member States, Turkey or
Norway about the chemical precursors or manufacturing
methods used to make MDPV. Methods for the production of
MDPV are documented in the scientific literature.
3.8.2. The mode and scope of the established or expected use of the new substance
MDPV has been marketed and sold through online shops as a
branded ‘legal high’ product and as a ‘research chemical’.
MDPV was not declared as an ingredient of the products. This
has been confirmed by Denmark, Slovakia and the United
Kingdom, each of which reported finding MDPV in samples of
branded ‘legal high’ products purchased from the Internet.
Furthermore, both Ireland and Poland reported significant
numbers of branded ‘legal high’ products collected from
bricks and mortar shops (Kelleher et al., 2011). It is also
important to note that information from the Member States
(such as seizures, collected samples and non-fatal
intoxications) and also from user websites suggests that
MDPV may be commonly sold as a ‘legal’ replacement for
cocaine, amphetamine or MDMA. It is also sold directly on the
illicit drug market as these drugs (26). The use of MDPV by
injecting drug users has also been noted (see below). As a
result, the mode and scope of use of MDPV may, in part,
overlap and/or reflect the mode and scope of use of other
stimulants used in recreational settings and by problematic
drug users, including those who inject. Additional research is
required in order to examine to what extent, if any, the mode
and scope of MDPV use overlaps with and/or reflects those
groups.
(26) Other NPS and adulterants such as caffeine and lidocaine have been found in samples.
Settings of use
One of the reports of deaths provided by Poland noted the use
of MDPV in the context of recreational use (at a party).
Samples have been collected from dance venues in Austria
and the Netherlands, where it was reported to have been sold
as mephedrone, cocaine, MDPV and speed (Austria), and
cocaine, synthetic cocaine, ‘moji’, 6-APB, 5-APB, MDPV and
‘meferon’ (the Netherlands). France reported that MDPV was
‘generally used at home during sexual context’ (not further
described). Sweden reported that ‘MDPV was popular two
years ago among stimulant users, age group 20–30 years;
they used MDPV at parties or at home (private parties that
lasted from Friday night [until] Sunday night) and at times not
regularly; at the moment MDPV is not present, the users
stopped using it because of negative side effects, mostly
depression and strong craving.’
Price
Six countries reported the price of MDPV. France reported
that MDPV was sold at between EUR 2–15 per gram. Hungary
reported a price of EUR 13.5 (quantity not specified). Italy
reported that prices were from EUR 14.95 for 0.5 g to EUR 169
for 10 g (source: www.spicestore247.biz/mdpv-1). The
Netherlands reported information from a forum discussion
that included prices for MDPV of EUR 35 per gram and
EUR 160 for 5 g. Romania reported a price of EUR 25 (quantity
not specified). Spain reported that when MDPV was sold as
cocaine the price was EUR 50–60 per gram and when it was
sold as MDPV the price was EUR 20 per gram. In 2011 the
EMCDDA conducted a study of Internet sites selling new
psychoactive substances (EMCDDA, 2012). MDPV was found
to be on sale in January 2011 and July 2011 in 25 and 32
shops respectively and the price was reported to be EUR 115–
239 for 10 g.
I 3.8.3. Other use of the new psychoactive substance
and the extent of such use, the risks associated with this use of the new psychoactive substance, including the health and social risks
No information was provided by any Member State, Turkey or
Norway that indicated that MDPV had any other use apart
from legitimate scientific research and as an analytical
reference standard.
JOINT REPORTS I MDPV
18 / 34
From the available information it does not appear that MDPV
is used in the manufacture of a medicinal product in the
European Union. However, the collection of information cannot
be considered exhaustive in the absence of a European Union
database on the synthetic routes of all medicinal products (27).
I 4. Information from the EMA as requested by Article 5.3 of the Decision
I 4.1. Marketing authorisation
The 25 Member States, Norway and Iceland responded to the
EMA’s information request (see section 2) reported that the
new psychoactive substance MDPV has not obtained a
marketing authorisation (28). The EMA also reported that the
new psychoactive substance MDPV has not obtained a
marketing authorisation through the central authorisation
procedure.
I 4.2. Application for a marketing authorisation
Twenty-five Member States, Norway and Iceland responded to
the EMA’s information request (see section 2) reported that
the new psychoactive substance MDPV is not the subject of
an application for a marketing authorisation (28). The EMA also
reported that the new psychoactive substance MDPV is not
the subject of an application for a marketing authorisation
through the central authorisation procedure.
(27) I.e. products that have been granted a marketing authorisation, or where an application for a marketing authorisation has been made, or where the marketing authorisation has been suspended.
(28) Austria, Belgium, Croatia, the Czech Republic, Denmark, Estonia, Germany, Greece, Hungary, Iceland, Ireland, the Netherlands, Norway, Portugal, Slovenia, Spain, Sweden and the United Kingdom provided responses in relation to both human and veterinary medicinal products. Cyprus, Italy, Lithuania, Malta, Romania and Slovakia provided responses in relation to human medicinal products. France, Latvia and Poland provided responses in relation to veterinary medicinal products. In addition, the EMA provided information in relation to both human and veterinary medicinal products in respect of the central authorisation procedure.
I 4.3. Suspended marketing authorisation
Twenty-five Member States, Norway and Iceland responded to
the EMA’s information request (see section 2) reported that
there had been no cases of a suspended marketing
authorisation that had been granted in respect of the new
psychoactive substance MDPV (28). The EMA also reported
that the new psychoactive substance MDPV is not the subject
of a suspended marketing authorisation through the central
authorisation procedure.
I 5. Conclusions
MDPV is a synthetic cathinone derivative, which is closely
related to pyrovalerone. MDPV has been present in the EU
drug market since at least November 2008 and has been
detected in up to 107 non-fatal intoxications and 99 deaths,
particularly in Finland and the United Kingdom. There are
some indications that it has been sold as a ‘legal’ or synthetic
version of cocaine and it has also been found in tablets
resembling ‘ecstasy’. Large seizures have been made at
borders and police operations have targeted its supply.
Powder seizures have been reported, including multi-kilogram
quantities. Most, but not all the Member States have control
measures at the national level that cover MDPV; however, it
continues to be available and this is concerning. We conclude
that the health and social risks caused by the manufacture,
trafficking and use of MDPV, and in particular the involvement
of organised crime and possible consequences of EU-level
control measures, could be thoroughly assessed through a
risk assessment procedure in accordance with Article 6 of
Council Decision 2005/387/JHA.
JOINT REPORTS I MDPV
19 / 34
References
I Aarde, S. M., Huang, P. K., Creehan, K. M., Dickerson, T. J. and Taffe, M. A. (2013), ‘The novel
recreational drug 3,4-methylenedioxypyrovalerone (MDPV) is a potent psychomotor stimulant:
self-administration and locomotor activity in rats’, Neuropharmacology, 71, pp. 130–140.
I Adamowicz, P., Gil, D., Skulska, A. and Tokarczyk, B. (2013), ‘Analysis of MDPV in blood: determination
and interpretation’, Journal of Analytical Toxicology, 37, pp. 308–312.
I Bäckberg, M., Westerbergh, J., Al-Saffar, Y., Lindeman, E. and Helander, A. (2013), ‘Trends in
intoxications of novel psychoactive substances in Sweden during 2012’, Clinical Toxicology, 51, pp.
256–257.
I Baumann, M. H., Clark, R. D., Woolverton, W. L., Wee, S., Blough, B. E. and Rothman, R. B. (2011), ‘In
vivo effects of amphetamine analogs reveal evidence for serotonergic inhibition of mesolimbic
dopamine transmission in the rat’, Journal of Pharmacology and Experimental Therapeutics, 337, pp.
218–225.
I Baumann, M. H., Partilla, J. S., Lehner, K. R., Thorndike, E.B., Hoffman, A.F., Holy, M., Rothman, R.B.,
I Annex 1 Images of MDPV from seizures and collected samples
JOINT REPORTS I MDPV
22 / 34
Annex 1
Country Image Description
Italy Seizures: 2011
Numerous seized samples (powders, agglomerated powders, tablets), seized in Treviso.Contents: MDPV, 4-FA, cocaine and lidocaine or procaine.Seizing authority: Police Department, Treviso
Malta
Seizure: March 2011
30 packets containing white powder — 15 g in all. Seized in Attard (EUR 13.5 per gram).Seizing authority: Police Drug Squad
Slovakia Collected sample, analysed in March 2010
310 mg deep blue powder, colourless capsule.Contents: MDPV and mephedrone not quantified.Collecting authority: National Drug Service of Bureau of Fight Against Organised Crime, Police Force Headquarters; analysis was completed by Institute of the Forensic Science of Police Force (IFS).
Slovakia Collected sample, analysed in September 2010
310 mg white powder, colourless capsule.Contents: MDPV and Butylone not quantified.Collecting authority: National Drug Service of Bureau of Fight Against Organised Crime, Police Force Headquarters; analysis was completed by Institute of the Forensic Science of Police Force (IFS).
JOINT REPORTS I MDPV
23 / 34
Non-fatal intoxications
Country Date Sample type MDPV result Results for other substances Notes
Belgium Aug 2011(F, 31)
Urine + Cocaine (+) Amphetamines (+)
First-time MDPV use. Drug taken orally. Symptoms included hallucinations and severe psychosis, paranoia, visual and auditory hallucinations, aggressiveness. Hypertension, tachycardia. Treated with antipsychotics. Status normal after 3–4 days.
Belgium Aug 2011(M, 34)
Urine + Cocaine (+) Amphetamines (+)
First-time MDPV use. Drug taken orally. Symptoms included hallucinations and severe psychosis, paranoia, visual and auditory hallucinations, aggressiveness. Hypertension, tachycardia. Treated with antipsychotics. Status normal after 3–4 days.
Man brought in to the emergency department by the police.
France Date not specified(M, 25)
Blood + Methylone (4400 ng/mL) Symptoms included tachycardia, mydriasis, hypertension, agitation, profuse sweating, trembling, scarification, rhabdomyolysis. Paranoid psychosis, aggressivity. Route of administration: inhaled and oral. 10 g. Bought on the Internet. In combination with methylone.
Forced hospitalisation.
France Date not specified(M, 22)
Hair + Alcohol (+) Cannabis (+)
Intranasal ingestion. Duration of action: 2 days.
Symptoms: mydriasis, paranoid psychosis.
Italy Aug 2011(M, 20)
Urine 14 mg/L Butylone (+) On admission, the patient was very agitated with tachycardia (Fc 115 bpm). He reported having consumed cannabis, alcohol and 3 white capsules. He was treated with benzodiazepine and discharged 2 days later.
The patient was admitted to the emergency department and reported having consumed (sniffing) ecstasy and synthetic drugs generally named as ‘mefre, crystal and energy’.
Symptoms included agitation, mild tachycardia (Fc 105 bpm), distress, psychotic symptoms and visual and auditory hallucinations. During the first 24 hours the patient was treated with fluids, benzodiazepine and haloperidol and was transferred to a psychiatric ward.
I Annex 2 Non-fatal intoxications and deaths where MDPV has been analytically confirmed in biological samples
Country Date Sample type MDPV result Results for other substances Notes
Italy Oct 2012(M, 27)
Urine On admission: = 55 µg/L3 days after admission: 35 µg/L
On admission:Alprazolam (113.79 µg/L)Hydroxyalprazolam (103.59 µg/L)
3 days after admission:Chlordiazepoxide (13.03 µg/L)Nordiazepam (61.55 µg/L)Oxazepam (114.99 µg/L)Diazepam (1.26 µg/L)Temazepam (169.90 µg/L)Alprazolam (10.43 µg/L)Alpha-hydroxyalprazolam (13.45 µg/L)
On arrival in the emergency department the patient reported having consumed 3,4-methylenedioxypyrovalerone (MDPV) intravenously for the last 3–4 days, together with benzodiazepine, to counteract the excitatory effect of MDPV. Symptoms included psychomotor agitation, confusion and anxiety. Anamnestic information from the patient revealed previous use of pentedrone and 3-methylmethcathinone abandoned due to decreased interest on these substances.
Three days after admission, the patient had a second urine analyses, and reported having continued his use of MDPV.
MDPV was purchased via the Internet and marketed as ‘bath salt’.
Sweden Jan–Sep 2012 BloodUrine
+ Result for other substances was positive for 15/17 cases with severe symptoms.Benzodiazepines (7) were the most frequently identified substances.Medicines included buprenorphine, tramadol and fentanyl.
From a total of 86 cases, in 17 cases the symptoms were severe (Poisoning Severity Score — PSS 3) and consisted of extreme agitation, psychosis, hyperthermia, tachycardia, hypertension, myocardial infarction, rhabdomyolysis and renal failure. A few patients needed therapy with sedatives for several days due to prolonged symptoms.
See Bäckberg et al. (2013) for further details.
Sweden Apr–May 2012 Not specified + None reported Twelve of the 13 cases described were classified as chronic drug users, with >60 % noted to be HCV positive.
See Lindeman et al. (2013) for further details.
JOINT REPORTS I MDPV
25 / 34
Annex 2
Deaths
Country Date Biological sample MDPV resultResults of toxicological analysis for other substances
Notes
1 Austria Jan 2012(M)
Not specified + Butylone (+)Methylone (+)4-methylethcathinone (+)Cocaine (+)
Butylone (bk-MBDB) overdose in combination with methylone, 4-methylethcathinone and cocaine.
Country Date Biological sample MDPV resultResults of toxicological analysis for other substances
Notes
38 Finland Dec 2012 Blood 30 mg/mL Doxepine (1.5 mg/L)Citalopram (1.9 mg/L)Quetiapine (1.3 mg/L)α-PVP (0.070 mg/L)Buprenorphine (0.029 mg/L)Temazepam (<LOQ)
Suicide, doxepin poisoning.
39 Finland Jan 2013 Urine + Ethanol (1.6 g/kg)Alprazolam (0.005 g/l)Diazepam (0.45 g/l)Codeine (0.15 g/l)Buprenorphine (0.0006 g/L)
Cause of death not yet registered.
40 Finland Apr 2013 Blood 30 mg/mL Trimethoprim (1.6 mg/L) Cause of death not yet registered.
41 Finland Aug 2013 Urine + Alprazolam (0.044 mg/L)Diazepam (0.092 mg/L)THC (39) (0.0051 mg/L)Buprenorphine (0.0012 mg/L)Fentanyl (0.0082 mg/L)Pregabalin (4.0 mg/L)
Cause of death not yet registered.
42 France Oct 2012 BloodUrine
106 µg/L (blood)760 µg/L (urine)
PVP(40 µg/L in blood)(295 µg/L in urine)
Pentedrone(33 µg/L in blood)(110 µg/L in urine)
Hydroxyzine (194 µg/L in blood)Nordazepam (47 µg/L in blood)Oxazepam (8 µg/L in blood)Cannabinoic acid (15.7 µg/L in blood)Ethanol (0.3 g/L in blood)
Cause of death: drowning.
43 Norway 2012 Blood + None reported Cause of death not reported.
44 Poland Sep 2010 Blood 430 ng/mL Ephedrine (324 ng/mL) Cause of death: ‘metabolic dysfunction’ caused by MDPV.
45 Poland 2011 Blood 38 ng/mL Buphedrone (127 ng/mL) Indirect death: car accident. During inspection of the deceased driver, the police found packages of white powder, labelled ‘Ivory Speed’ and ‘Exclusive Dust’, and a note reading ‘collector’s product for field stone rinsing’.See Adamowicz et al. (2013) for further information.
Death after a night of partying. A witness testified that the man had taken a product called ‘Speedway’.The autopsy showed emaciation, external hydrocephalus and atherosclerosis. Deceased with a history of drug addiction, HIV+.See Adamowicz et al. (2013) for further information.
(39) D9-tetrahydrocannabinol, the main psychoactive substance in cannabis.
JOINT REPORTS I MDPV
30 / 34
Annex 2
Country Date Biological sample MDPV resultResults of toxicological analysis for other substances
Notes
47–
49
Sweden 2010 Not specified + None reported 3 cases.The deaths were intoxications involving several substances (not further described).
50–
52
Sweden 2011 Not specified + None reported 3 cases.None of the 3 deaths related only to MDPV.
53–
61
Sweden 2012 Not specified + None reported 9 cases.There were several accidents, death by hanging and intoxications with several drugs (not further described).
62–
67
Sweden 2013 Not specified + None reported 6 cases.There was one car accident and intoxications with several drugs (not further described).
68–
69
United Kingdom Jan-Dec 2010 BloodUrine
+ Case 1:Fluoromethcathinone (+)Mirtazapine(+)Olanzapine (+)Amphetamine (+)
Case 2:Fluoromethcathinone (+)Ibuprofen(+)
2 cases.Case 1: hit by train.Case 2: bag over head.
3 cases.Case 1: hanging.Case 2: no circumstances reported.Case 3: found at home.
(40) Methylenedioxymethylamphetamine (commonly known as ‘ecstasy’).(41) 3,4-methylenedioxyaminoindane.(42) 5-iodoaminoindane.(43) Alpha-methyltryptamine.
JOINT REPORTS I MDPV
31 / 34
Annex 2
Country Date Biological sample MDPV resultResults of toxicological analysis for other substances
Notes
73–
83
United Kingdom** Jan–Dec 2012 BloodUrine
+ None reported 11 cases.6 cases of hanging.1 case murder victim.1 case murder suspect.2 cases found dead at home.1 case found in a canal.1 case found dead in a car (carbon monoxide poisoning).
(One of the cases is a duplicate, although it is not certain which one, hence this group is counted as 11 cases — see death 99)
Coronary artery disease in the presence of MDPV.Coroner’s verdict: open verdict/unascertained.
86 United Kingdom Feb 2010(M, 34)
BloodGastric
+ (blood) Fentanyl(24 ng/mL in blood)(37 µg in gastric sample)
Cannabis (+)
Fentanyl toxicity implicated.Coroner’s verdict: open verdict/unascertained.
87 United Kingdom Jul 2010(M, 26)
BloodGastric
+ (blood)+ (gastric)
Pyrovalerone(+ in blood)(+ in gastric sample)
THC-acid (44) (+ in blood)Lignocaine (+ in antemortem blood)Amiodarone (+ blood, therapeutic use suspected)
Cause of hypovolaemic shock: laceration of left forearm associated with partial transection of cephalic vein.Toxic effects of pyrovalerone and MDPV.Coroner’s verdict accidental/misadventure.
88 United Kingdom Apr 2010(F, 45)
Blood + Mephedrone (+)GBL (45) (+)Methylone (+)
Mixed drug toxicity. Implicated: methedrone, GBL and methylone. Cause of death: non-dependent abuse of drugs.Coroner’s verdict: open verdict/unascertained.
89 United Kingdom Nov 2010(F, 29)
BloodUrine
<LOD (blood)+ (urine)
Alcohol(63 mg/100mL in blood)(118 mg/100mL in urine)
Mephedrone(<LOD (46) in matrix unknown)
cocaine (+ in urine)levamisole (+ in urine)quinine (+ in urine)
Multiple injuries. Had taken a variety of substances and alcohol.Coroner’s verdict: suicide. Implicated drugs alcohol, mephedrone and MDPV.
(44) D9-tetrahydrocannabinolic acid, a breakdown product of D9-tetrahydrocannabinol, the main psychoactive substance in cannabis.(45) Gammabutyrolactone.(46) Limit of detection — the lowest amount that can be detected by the method used.
JOINT REPORTS I MDPV
32 / 34
Annex 2
Country Date Biological sample MDPV resultResults of toxicological analysis for other substances
Drowning and multiple drug overdose. Implicated: MDMA, cocaine and mephedrone.Coroner’s verdict: accidental/misadventure.
(47) Trifluoromethylphenylpiperazine.(48) Methylenedioxymethylamphetamine (commonly known as ‘ecstasy’).
JOINT REPORTS I MDPV
33 / 34
Annex 2
Country Date Biological sample MDPV resultResults of toxicological analysis for other substances
Notes
96 United Kingdom May 2011(M, 53)
BloodUrine
+ MDPBP (49)(1.55 mg/l in blood),(94.2 mg/l in urine)
Pentylone(0.34 mg/l in blood)(29.4 mg/l in urine)
Mephedrone(+ in matrix unknown)
Cocaine (+ in urine)
Cause of death: ischaemic heart disease and illicit use of cathinones. Implicated drugs: mephedrone, MDPBP and pentylone.Coroner’s verdict accidental/misadventure.
97 United Kingdom Dec 2011(M, 56)
Not specified + MDMA (+)Cocaine (+)Cathinone (+)
MDMA, cocaine, MDPV and methylmethcathinone toxicity. Implicated: ecstasy, cocaine and cathinones.Coroner’s verdict: open verdict/unascertained.
98 United Kingdom Aug 2011(M, 27)
Unspecified + None reported MDPV and heart attack.Coroner’s verdict: open verdict/unascertained.
99 United Kingdom** Apr 2012(M, 31)
Blood <0.1 mg/L AMT (50) (0.89 mg/L) Cause of death: cardiac failure, MDPV and AMT drug toxicity plus left ventricular hypertrophy and obesity.Coroners’ verdict: accidental/misadventure.
In this table LOD is the limit of detection and LOQ is the limit of quantitation.* All cases in Finland are from medico-legal source and include suspect and unnatural deaths, non-related to poisoning.** The United Kingdom reported data on fatal intoxications from two separate sources, ROAR Forensics and the national programme for Substance Abuse Deaths (np-SAD). It should be noted that, based on case-specific details, case 99 is believed
to be a duplicate of one of the cases reported in the aggregated data from 2012, and has been counted once only.
European Monitoring Centre for Drugs and Drug Addiction (2014), EMCDDA–Europol Joint
Report on a new psychoactive substance: MDPV (3,4-methylenedioxypyrovalerone), Joint
Reports, Publications Office of the European Union, Luxembourg.
About the EMCDDA
The European Monitoring Centre for Drugs and Drug Addiction is the hub of drug-related
information in Europe. Its mission is to provide the European Union and its Member States
with ‘factual, objective, reliable and comparable information’ on drugs and drug addiction
and their consequences. Established in 1993, it opened its doors in Lisbon in 1995, and is
one of the European Union’s decentralised agencies. The Centre offers policymakers the
evidence base they need for drawing up drug laws and strategies. It also helps
professionals and researchers pinpoint best practice and new areas for analysis.
Related publications and websites
EMCDDA
I European Drug Report 2013: Trends and developments, 2013
EMCDDA and Europol
I EMCDDA–Europol 2012 Annual Report on the implementation of Council Decision
2005/387/JHA (New drugs in Europe, 2012), Implementation reports, 2013
I EMCDDA Action on new drugs: www.emcdda.europa.eu/drug-situation/new-drugs
These and all other EMCDDA publications are available from
www.emcdda.europa.eu/publications
Legal notice: The contents of this publication do not necessarily reflect the official opinions of the EMCDDA’s partners, the EU Member States or any institution or agency of the European Union. More information on the European Union is available on the Internet (europa.eu).
Luxembourg: Publications Office of the European Uniondoi: 10.2810/24085 I ISBN 978-92-9168-680-3